NCT05737186TerminatedPhase 4
SGLT2 Inhibitors and Treatment of Heart Failure in Severe Renal Insufficiency
The Efficacy and Safety of SGLT2 Inhibitors in Improving Heart Failure in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Severe Renal Insufficiency
Source: ClinicalTrials.gov · Last updated 30 Apr 2024
Reason given: Double blind packaged drug is up to expiration date
Brief summary (registry, in English)
In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with chronic kidney disease (CKD) stage 4, but there is little clinical evidence in patients with eGFR<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR<20ml/min/1.73m2).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 12 Feb 2023
- Start date
- 9 Mar 2023
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Heart failure
- NCT number
- NCT05737186
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization
- Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization
- Drug or alcohol addicts
- Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period
Other illness
- Allergy to SGLT-2i
- Urinary or reproductive system infection in the last month
- Patients with acute heart failure
- Uncontrolled serious arrhythmia
- Patients with malignant tumors
- Type 1 diabetes
Lab values
- ALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal value
- Blood potassium is greater than or equal to the upper limit of normal value
- Hemoglobin<90g/L
Other
- Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics
- Patients who need intravenous vasodilators, including nitrates, before randomization
- Systolic blood pressure<100mmHg measured during screening or at randomization
- Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period
- Patients with uncontrolled abnormal thyroid function
- Not suitable evaluated by the investigator
Who the study is looking for
- Age 20-75 years
- Patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, New York Heart Association (NYHA) grade II-IV
- Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year
- Clinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2 or maintenance hemodialysis
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.